Evidence map›Paper›PMID 25887777›Full record

ArticleBlood2015

A phase 1 study of the bispecific anti-CD30/CD16A antibody construct AFM13 in patients with relapsed or refractory Hodgkin lymphoma.

Achim Rothe, Stephanie Sasse, Max S Topp, Dennis A Eichenauer, Horst Hummel, Katrin S Reiners, Markus Dietlein, Georg Kuhnert, Joerg Kessler, Carolin Buerkle and 6 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase I
In one paragraph

Article in Blood, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01221571 (A Pharmacodynamically-Guided Dose Escalation Phase I Study to Assess the Safety of AFM13), which is not on this map. Cited by 180 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
180citing papers in PubMed, 2 pooled it
19.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01221571 phase1completednot on this map

A Pharmacodynamically-Guided Dose Escalation Phase I Study to Assess the Safety of AFM13 (Recombinant Antibody Construct Against Human CD30 and CD16A) in Patients With Refractory and/or Relapsed Hodgkin Lymphoma

TypeinterventionalSponsorAffimed GmbHRan2010 to 2013Enrolled28ConditionsHodgkin LymphomaArmsAFM 13
3 · Its place in the literature

Who cites it

180 citing papers in PubMed, 2 syntheses or guidelines pooled it, 321 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. A Phase II Study of Acimtamig (AFM13) in Patients with CD30-Positive, Relapsed, or Refractory Peripheral T-cell Lymphomas.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Review
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  11. Review
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  15. Classical Hodgkin Lymphoma Today.Mediterranean journal of hematology and infectious diseases · 2026
    Review
  16. Review
  17. Review
  18. Bispecific Antibodies in Hematologic Malignancies: Attacking the Frontline.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  19. Review
  20. Harnessing engineered NK cells for refractory CD30+ lymphoma.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Article

120 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 3 institutions in 1 country.

Achim RotheDepartment I of Internal Medicine, and Innate Immunity Group, Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany;
Stephanie SasseDepartment I of Internal Medicine, and.
Max S ToppDepartment of Internal Medicine II, Division of Hematology and Medical Oncology, Wuerzburg University Medical Center, Wuerzburg, Germany;
Dennis A EichenauerDepartment I of Internal Medicine, and.
Horst HummelDepartment of Internal Medicine II, Division of Hematology and Medical Oncology, Wuerzburg University Medical Center, Wuerzburg, Germany;
Katrin S ReinersInnate Immunity Group, Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany;
Markus DietleinDepartment of Nuclear Medicine, University Hospital of Cologne, Cologne, Germany; and.
Georg KuhnertDepartment of Nuclear Medicine, University Hospital of Cologne, Cologne, Germany; and.
Joerg KesslerInnate Immunity Group, Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany;
Carolin BuerkleDepartment I of Internal Medicine, and.
Miroslav RavicAffimed, Heidelberg, Germany.
Stefan KnackmussAffimed, Heidelberg, Germany.
Jens-Peter MarschnerAffimed, Heidelberg, Germany.
Elke Pogge von StrandmannInnate Immunity Group, Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany;
Peter BorchmannDepartment I of Internal Medicine, and.
Andreas EngertDepartment I of Internal Medicine, and.
University Hospital Cologne · DEAffimed Therapeutics (Germany) · DEUniversity of Würzburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

AFM13 is a bispecific, tetravalent chimeric antibody construct (TandAb) designed for the treatment of CD30-expressing malignancies. AFM13 recruits natural killer (NK) cells via binding to CD16A as immune effector cells. In this phase 1 dose-escalation study, 28 patients with heavily pretreated relapsed or refractory Hodgkin lymphoma received AFM13 at doses of 0.01 to 7 mg/kg body weight. Primary objectives were safety and tolerability. Secondary objectives included pharmacokinetics, antitumor activity, and pharmacodynamics. Adverse events were generally mild to moderate. The maximum tolerated dose was not reached. Pharmacokinetics assessment revealed a half-life of up to 19 hours. Three of 26 evaluable patients achieved partial remission (11.5%) and 13 patients achieved stable disease (50%), with an overall disease control rate of 61.5%. AFM13 was also active in brentuximab vedotin-refractory patients. In 13 patients who received doses of ≥1.5 mg/kg AFM13, the overall response rate was 23% and the disease control rate was 77%. AFM13 treatment resulted in a significant NK-cell activation and a decrease of soluble CD30 in peripheral blood. In conclusion, AFM13 represents a well-tolerated, safe, and active targeted immunotherapy of Hodgkin lymphoma. A phase 2 study is currently planned to optimize the dosing schedule in order to further improve the therapeutic efficacy. This phase 1 study was registered at www.clinicaltrials.gov as #NCT01221571.

Indexed as

AdultAgedAntibodies, BispecificDose-Response Relationship, DrugFemaleHodgkin DiseaseHumansImmunotherapyKi-1 AntigenMaleMiddle AgedReceptors, IgGRecurrenceYoung AdultAntibodies, BispecificFCGR3A protein, humanKi-1 AntigenReceptors, IgG

Identifiers

PMID25887777
PMCPMC4528081
OpenAlexW2123023182

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.